MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	5530-G-609
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	05/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was reported that all information available has been submitted.Should additional information become available it will be reported in a supplemental report.The following device was also listed in this report: 5554l381,triathlon mb patella pa a38.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not available.
Event or Problem Description
It was reported: "pain and stability complaints.All information available has been submitted".
Additional Manufacturer Narrative
Reported event: an event regarding instability involving a triathlon insert was reported.The event was not confirmed.Method & results: -product evaluation and results: no product was returned for evaluation however two photographs were provided for review.The photographs show a recently explanted patella and insert components.Blood is visible on both components.Yellow discoloration was also observed on the insert, consistent with absorption of synovial fluid, invivo use.Damage/wear is visible on the posterior compartments of the insert.The patella appears unremarkable.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: cannot confirm event, need additional information; revision operative reports, clinical and past medical history, additional serial x-rays.-product history review: indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as device identification, revision operative reports, additional serial x-rays as well as clinical and past medical history are required to complete the investigation for determining a root cause.The following device was also listed in this report: 5554l381,triathlon mb patella pa a38.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It was reported: "pain and stability complaints.All information available has been submitted".

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8650203
• Report Number: 0002249697-2019-02121
• Device Sequence Number: 11272463
• Product Code: JWH
• UDI-Device Identifier: 07613327050585
• UDI-Public: 07613327050585
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 5530-G-609
• Device Lot Number: MLDMLJ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 118